Barden are delighted to be supporting our Global Biopharmaceutical client in their search for an Associate Director – Quality Assurance for their Limerick facility.
ABOUT THE ROLE:
This is a unique opportunity to be a part of the leadership team for the startup of a greenfield manufacturing site, and the successful person will help to build the organization, the facility and the culture to enable a successful startup GMP manufacturing operation.?
As members of the quality management team the Associate Director Quality Assurance is a key leader in the cross functional support of the manufacturing, warehouse and/or quality control operations. The Associate Director QA is responsible for QA business processes including support of GMP and GLP compliance, regulatory inspection readiness, Quality Plan and continuous improvement projects and will provide leadership and direction to the QA team across their area.
Roles & Responsibilities:
- Be an active member of management team understanding the business and their role to ensure the business objectives are met.
- Supervision and coaching of their QA team members including completing performance reviews and development planning, to ensure continued growth of technical depth and capability with the team.
- Manage training, qualification and performance of the team. Set job expectations and goals for individuals linked to team/site goals.
- Communicate appropriately with team members regarding site objectives and team business.
- Ensures that adequate resources are in place to support operations, new product introductions, batch disposition and quality system activities and productivity/continuous improvement initiatives in their area of responsibility.
- Review and approve specific quality documents consistent with procedural requirements; including, but not limited to, deviations, change controls, procedures, annual product reviews and validation documentation.
- Responsible for the escalation of critical quality issues as appropriate to Quality Management consistent with site procedure on Notification to Management.
- Provides technical leadership and advice for key Quality issues.
- Identify, prioritise, and support the implementation of continuous improvement initiatives, to maintain compliance while striving to meet business and customer needs.
- Maintain a continued state of cGMP compliance and readiness for Pre-Approval Inspections (PAIs) and Routine GMP Inspections by regulatory agencies.
- Promote continued alignment in Quality assurance business processes.
- Specifically, during the startup phase (2023 to 2025) this role will be expected to be a collaborative, inclusive, energetic leader and support the broader team.
- Build the organization with the necessary capability, capacity and culture to operate this facility to the highest standards of excellence.
- Develop and implement the systems and processed needed to run the site, leveraging existing knowledge and practices where necessary, but also incorporating external experiences and learning.
- Ensure regulatory compliance and operational excellence by supporting lean principles and a Digitally Native approach.
- Support the project team as they deliver the facility to the site team, by providing feedback and support on decisions & strategies etc. Collaborate with them to ensure the right decisions are made to meet project deliverables and longer-term strategic goals for the site.
ABOUT THE PERSON:
Education & Work Experience:
- Bachelor of Science, Engineering, QP or equivalent Quality Management Qualifications
- Preferred > 6 years GMP Manufacturing experience and at least 1 year experience in leading a manufacturing support team in a Pharmaceutical/Bio-pharmaceutical setting.
- Business Knowledge: High performance in delivery of their work. Looks at better, simpler ways, takes initiative and will run proactively with actions. Demonstrated self-management, prioritisation and organisational skills.
- Learning agility and Curiosity: High learning agility and flexibility and ability to deal with ambiguity and uncertainty. Demonstrated ability to identify and prioritize problems, develop and implement solutions.
- Positive Influence: Demonstrated ability to address issues as they arise and take action. Trusted in the team to follow through on actions. Is interested in own performance and seeks feedback to improve.
- Relationship Builder: Demonstrated ability to establish and maintain key relationships across all levels in the organisation.
- Ability to lead people: Demonstrated ability to lead and motivate in a team environment. Demonstrated ability to influence peers and across functions.
- Communication: Demonstrated strong communication skills, written and oral in 1:1 and group situations.
- Decision Making: Demonstrated ability to be decisive and make well informed decisions for the benefit of the team. Demonstrated ability to collate required information and ask the appropriate questions of peers to get to the best solution.
Hi, we’re Barden. We’re the Partner Led Talent Advisory & Recruitment Firm that puts Talent first. With practices across Accounting & Tax, Business Support, Financial Services, Legal, Life Sciences, Supply Chain, and Technology, we help build world-class teams for Ireland’s top companies and we help top Talent achieve their ambitions. Simple.